Septic ShockSURFNCT03438097
Survey of Non-resuscitation Fluids in Septic Shock
An observational study of Septic Shock, run by Region Skane at 9 sites in 2 countries.
Trial summary
The objective of this study is to survey the type and the amount of non-resuscitation fluids that patients with septic shock receives during their first 5 days of ICU admission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- How many people
- 200 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 1 Mar 2018to 15 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients admitted with septic shock during a 4 month period in ICUs in Sweden and in British Columbia, Canada. A maximum of 30 patients per centre will be recruited.
Who may be able to join
- Septic shock per SEPSIS-3 criteria within 24 hrs of ICU admission
- Informed consent from patient or next of kin if required by local ethical review Board
Who cannot join
- Lack of informed consent (see above)
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Sweden7 sites
ICU Halmstad Hospital
Halmstad
ICU Helsingborg Hospital
Helsingborg
ICU Kristianstad Hospital
Kristianstad
ICU Skane University Hospital
Lund
Department of Infections Diseases
Malmö
ICU Skane University Hospital
Malmö
ICU Ystad Hospital
Ystad
Canada2 sites
St Paul's Hospital
Vancouver, British Columbia
Vancouver General Hospital
Vancouver, British Columbia
About this study
The objective of this study is to survey the type and the amount of non-resuscitation fluids that patients with septic shock receives during their first 5 days of ICU admission.
Read the detailed description
Background: Several studies indicate that a large part of the fluid intake in intensive care patients consists of fluids that are given for indications other than volume expansion. However, the type of non-resuscitation fluids that hemodynamically unstable ICU patients receive has not been well characterized.
Methods: A multicenter observational cohort study. Baseline data including, sex, age, physiological data at admission, source of sepsis, illness severity, and ICU and hospital mortality will be collected.
Fluids administered during the first five days of ICU admission will be registered. Fluids used as vehicle to administer drugs will be regarded as non-resuscitation fluids and will be characterized in detail. All glucose solutions will be regarded as non-resuscitation fluids. Crystalloids delivered at a rate of < 5 ml/kg/h will be considered as non-resuscitation fluids. Parenteral nutrition will be regarded as non-resuscitation fluids. Crystalloids delivered at a rate of ≥ 5 ml/kg/h will be considered to be resuscitation fluids. Blood products and colloids will be regarded as resuscitation fluids.
- Conditions
- Septic Shock
- Keywords
- Fluid therapy, Non-resuscitation fluids, Septic shock
- Medical subject headings
- Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
Type, indication and volume of fluids given to septic shock patients for other reasons than circulatory support.
Type of fluid is defined as either 0.9% normal saline, glucose, Ringers acetate/lactate, enteral nutrition, parenteral nutrition or sterile water.
Indication is defined as vehicle, nutrition, maintenance or other. Volume will be reported in ml.
Measured: First five days in ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Mar 2018
- Primary completion30 Jul 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, peter bentzer, Region Skane
- Investigators
- Peter Bentzer, MD, PhD, Principal investigator, Lund University, Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438097
- Sponsor's protocol ID
- ICU Skane 2017
- Acronym
- SURF
- Status last verified
- Aug 2018
- First submitted
- 9 Feb 2018
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Non-resuscitation Fluids in Septic Shock
- ClinicalTrials.gov ID
- NCT03438097
- Acronym / sponsor ID
- SURF / ICU Skane 2017
- Conditions
- Septic Shock
- Keywords
- Fluid therapy, Non-resuscitation fluids, Septic shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to survey the type and the amount of non-resuscitation fluids that patients with septic shock receives during their first 5 days of ICU admission.
Detailed description
Background: Several studies indicate that a large part of the fluid intake in intensive care patients consists of fluids that are given for indications other than volume expansion. However, the type of non-resuscitation fluids that hemodynamically unstable ICU patients receive has not been well characterized.
Methods: A multicenter observational cohort study. Baseline data including, sex, age, physiological data at admission, source of sepsis, illness severity, and ICU and hospital mortality will be collected.
Fluids administered during the first five days of ICU admission will be registered. Fluids used as vehicle to administer drugs will be regarded as non-resuscitation fluids and will be characterized in detail. All glucose solutions will be regarded as non-resuscitation fluids. Crystalloids delivered at a rate of < 5 ml/kg/h will be considered as non-resuscitation fluids. Parenteral nutrition will be regarded as non-resuscitation fluids. Crystalloids delivered at a rate of ≥ 5 ml/kg/h will be considered to be resuscitation fluids. Blood products and colloids will be regarded as resuscitation fluids.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients admitted with septic shock during a 4 month period in ICUs in Sweden and in British Columbia, Canada. A maximum of 30 patients per centre will be recruited.
Key inclusion criteria (2 listed)
- Septic shock per SEPSIS-3 criteria within 24 hrs of ICU admission
- Informed consent from patient or next of kin if required by local ethical review Board
Key exclusion criteria (1 listed)
- Lack of informed consent (see above)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Type, indication and volume of fluids given to septic shock patients for other reasons than circulatory support.
Time frame: First five days in ICU
Type of fluid is defined as either 0.9% normal saline, glucose, Ringers acetate/lactate, enteral nutrition, parenteral nutrition or sterile water. Indication is defined as vehicle, nutrition, maintenance or other. Volume will be reported in ml.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Individual participant dataSharing planned: Yes. On reasonable request
Related trials for Septic Shock
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Thymosin Alpha 1 and IgM Levels in Sepsis
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Bentzer, MD, PhD principal investigator
Lund University, Lund, Sweden
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Region Skane at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Sweden, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type, indication and volume of fluids given to septic shock patients for other reasons than circulatory support. (time frame: First five days in ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.